Amorphous rizatriptan benzoate
Rizatriptan benzoate in an amorphous form is disclosed. Also disclosed is a process for preparing rizatriptan benzoate substantially in amorphous form comprising the steps of (a) preparing a solvent solution comprising non-amorphous rizatriptan benzoate and one or more solvents capable of dissolving the non-amorphous rizatriptan benzoate; and (b) recovering the amorphous form of rizatriptan benzoate from the solution.
1 . Rizatriptan benzoate in an amorphous form.
2 . The amorphous rizatriptan benzoate of claim 1 , containing less than about 5% crystalline rizatriptan benzoate.
3 . A pharmaceutical composition comprising a therapeutically effective amount of the rizatriptan benzoate in an amorphous form.
4 . The pharmaceutical composition of claim 3 , further comprising a pharmaceutically acceptable carrier.
5 . The pharmaceutical composition of claim 3 , further comprising a pharmaceutically acceptable excipient.
6 . The pharmaceutical composition of claim 3 , which is in the form of a tablet or capsule.
7 . The pharmaceutical composition of claim 3 , wherein the amorphous rizatriptan benzoate is a micronized amorphous rizatriptan benzoate having a particle size of less than about 100 microns.
8 . A process for preparing rizatriptan benzoate in an amorphous form, the process comprising the steps of:
(a) preparing a solvent solution comprising non-amorphous rizatriptan benzoate and one or more solvents capable of dissolving the non-amorphous rizatriptan benzoate; and
(b) recovering the amorphous form of rizatriptan benzoate from the solution.
9 . The process of claim 8 , wherein the solvent is selected from the group consisting of water, alcohol and mixtures thereof.
10 . The process of claim 8 , wherein the alcohol is selected from the group consisting of methanol, ethanol, isopropanol and mixtures thereof.
11 . The process of claim 8 , wherein the step of recovering comprises distilling the solvent from the solution.
12 . The process of claim 8 , wherein the step of recovering comprises evaporating the solvent from the solution.
13 . The process of claim 8 , wherein the step of recovering comprises spray drying.
14 . The process of claim 8 , wherein the amorphous rizatriptan benzoate recovered in step (b) is substantially pure.
15 . The process of claim 8 , wherein the amorphous rizatriptan benzoate recovered in step (b) has a purity greater than or equal to about 98%.
16 . Rizatriptan benzoate in an amorphous form and having a purity greater than or equal to about 98%, prepared in accordance with claim 8.